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RECRUITINGEarly Phase 1INTERVENTIONAL

Short-Term Outcomes of Early Administration of Colchicine in Non-ST Segment Elevation Myocardial Infarction Patients Treated With Drug-Eluting Stents.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Inflammation plays a central role in the pathophysiology of atherosclerosis and in the progression of coronary artery. Colchicine, an anti-inflammatory agent traditionally used for gout and pericarditis, has emerged as a potential therapy in cardiovascular disease due to its ability to inhibit microtubule polymerization and suppress interleukin-1β and the NLRP3 inflammasome pathway. COLCOT and LoDoCo2 trails have demonstrated the efficacy of colchicine in reducing cardiovascular events in patients with coronary artery disease. However, more recent trials, including OASIS 9 and COVERT-MI trials did not support the use of a short-term colchicine treatment at the acute phase of ST segment elevation myocardial infarction (STEMI) to reduce infarct size and improve outcomes. Limited data exist on the peri-procedural use of colchicine in non-ST elevation myocardial infarction patients undergoing PCI. This study proposes to assess whether a loading dose of colchicine before PCI, followed by 3-months maintenance therapy, can improve short-term clinical outcomes and inflammatory markers in non- STEMI patients.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosed with Non-STEMI - Undergoing PCI with drug-eluting stents Who Should NOT Join This Trial: - Severe renal or hepatic dysfunction - Colchicine hypersensitivity - Active infection and active diarrhea. - Gastrointestinal intolerance - Pregnancy or breastfeeding. - Cardiogenic shock Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Diagnosed with Non-STEMI * Undergoing PCI with drug-eluting stents Exclusion Criteria: * Severe renal or hepatic dysfunction * Colchicine hypersensitivity * Active infection and active diarrhea. * Gastrointestinal intolerance * Pregnancy or breastfeeding. * Cardiogenic shock

Treatments Being Tested

DRUG

Colchicine

Administration of Colchicine 1 day before and 90 days after PCI in Non-STEMI Patients

DRUG

Placebo

Matching Placebo Regimen

Locations (1)

Assiut University Hospitals
Asyut, Asyut Governorate, Egypt